Surgical clip applier

ABSTRACT

Surgical clip appliers are provided and include a housing; at least one handle pivotably connected to the housing; a channel assembly extending distally from the housing; a clip carrier disposed within the channel assembly and defining a channel and a plurality of windows therein; and a plurality of clips slidably disposed within the channel of the clip carrier. The surgical clip appliers further include a drive channel reciprocally disposed within at least one of the housing and the channel assembly; a wedge plate reciprocally disposed within the channel assembly; a pusher bar reciprocally positioned within the housing and the channel assembly; and a motion multiplier system having a plurality of linkage members configured to distally move the pusher bar by an incremental amount upon an initial actuation of the handles, and configured to proximally move the pusher bar and the wedge plate subsequent to the initial actuation of the handles.

CROSS REFERENCE TO RELATED APPLICATION

The present application is a Continuation application which claims thebenefit of and priority to U.S. patent application Ser. No. 12/943,045,filed on Nov. 10, 2010 (now U.S. Pat. No. 8,545,486), which claims thebenefit of and priority to U.S. Provisional Application Ser. No.61/286,569, filed on Dec. 15, 2009, the entire content of each of whichis incorporate herein by reference.

BACKGROUND

1. Technical Field

The present application relates to surgical instruments, and moreparticularly, to surgical clip appliers having a plurality of clips forapplying the clips to body tissues and vessels during surgicalprocedures.

2. Discussion of Related Art

Surgical clip appliers are known in the art and have increased inpopularity among surgeons by offering an alternative to conventionalsuturing of body tissues and vessels. Typical instruments are disclosedin U.S. Pat. No. 5,030,226 to Green et al. and U.S. Pat. No. 5,431,668to Burbank III et al. These instruments generally provide a plurality ofclips which are stored in the instrument and which are fed sequentiallyto the jaw mechanism at the distal end of the instrument upon openingand closing of the handles at the proximal end of the instrument. As thehandles are closed, the jaws close to deform a clip positioned betweenthe jaw members, and as the jaws are opened to release the deformedclip, a new clip is fed from the series to a position between the jaws.This process is repeated until all the clips in the series of clips havebeen used.

Surgical clip appliers are typically available in a variety of sizesand/or scales ranging from relatively small, relatively medium torelatively large. Generally, each particular size of surgical clipappliers includes different components. As such, the method ofassembling the various sized surgical clip appliers differs from onesize to another.

As a consequence, each different size clip applier requires a differentstroke length of external components (e.g., clip applier actuation)that, in turn, affects different timing of internal components (e.g.,clip deployment components). The need therefore exists where certainessential components can be configured for each different sized clipapplier by only changing geometry without changing functionality.

In addition, the need therefore exists for a surgical clip applier thatis configured to accommodate simple internal components that function ina similar fashion as all of the different sized clip appliers, with onlychanging the geometry of the components. At the same time notcompromising a high clip pushing force with low driving force. Bettermotion and force characteristics and simpler components resulting inbetter performance of the device.

SUMMARY

The present application relates to surgical clip appliers having aplurality of clips for applying the clips to body tissues and vesselsduring surgical.

According to an aspect of the present disclosure, a surgical clipapplier is provided including a housing; at least one handle pivotablyconnected to the housing; a channel assembly extending distally from thehousing; a clip carrier disposed within the channel assembly anddefining a channel and a plurality of windows therein; a plurality ofclips slidably disposed within the channel of the clip carrier; a drivechannel reciprocally disposed within at least one of the housing and thechannel assembly, the drive channel having a first end operativelyconnected to the at least one handle and a second end operativelyconnected to a distal end of the channel assembly; a wedge platereciprocally disposed within the channel assembly, the wedge plate beingoperatively connected to the at least one handle and including aplurality of apertures formed along a length thereof; a pusher barreciprocally positioned within the housing and the channel assembly, thepusher bar having a proximal end operatively connected to at least onehandle and a distal end defining a pusher, wherein the distal end of thepusher bar is configured for engagement with a distal-most clip of theplurality of clips; and a motion multiplier system having a plurality oflinkage members configured to distally move the pusher bar by anincremental amount upon an initial actuation of the handles, andconfigured to proximally move the pusher bar and the wedge platesubsequent to the initial actuation of the handles.

The plurality of linkages of the motion multiplier system may include aproximal linkage member pivotally supported in the housing andoperatively connected to the drive channel; a pivoting drive arminterconnecting the drive channel and the proximal linkage member; and adistal linkage member interconnecting the proximal linkage member thepusher bar, such that a distal translation of the drive channel causes apivotal rotation of the proximal linkage member via the pivoting drivearm, wherein the pivotal rotation of the proximal linkage member causesa pivotal rotation of the distal linkage member. The pivotal rotation ofthe distal linkage member causes a distal translation of the pusher bar.The proximal linkage member may be pivotally connected to the housing bya pivot pin. The distal linkage member may be pivotally connected to theproximal linkage member.

A further distal translation of the drive channel may cause a furtherpivotal rotation of the proximal linkage member via the pivoting drivearm, wherein the further pivotal rotation of the proximal linkage membercauses a further pivotal rotation of the distal linkage member, andwherein the further pivotal rotation of the distal linkage member causesa proximal translation of the pusher bar.

In embodiments, when the proximal linkage member, the distal linkagemember, the pivoting drive arm, the drive channel and the pusher bar arein a first position, the proximal linkage member and the distal linkagemember define a first angle. Proximal translation of the drive channelcauses the proximal linkage member and the distal linkage member, viathe pivoting drive arm, to pivotally rotate thereby increasing the firstangle to a second angle of about 180 degrees such that the proximallinkage member and the distal linkage member are linear to each other,such that the proximal linkage member, the distal linkage member, thepivoting drive arm, the drive channel and the pusher bar are in a secondposition.

Further, when the proximal linkage member, the distal linkage member,the pivoting drive arm, the drive channel and the pusher bar are in thesecond position, further proximal translation of the drive channelcauses the proximal linkage member and the distal linkage member, viathe pivoting drive arm, to pivotally rotate thereby decreasing thesecond angle of about 180 degrees to a third angle, such that the distallinkage member, the pivoting drive arm, and the drive channel are in athird position, while the pusher bar is in the first position.

The rotation of the proximal linkage member via the pivoting drive armcauses the proximal linkage member and the distal linkage member to belinear to each other and along a longitudinal axis defined by areference axis between the proximal end of the proximal linkage memberand the distal end of the distal linkage member, such that the distallinkage member causes a distal translation of the pusher bar.

Further rotation of the proximal linkage member via the pivoting drivearm causes the proximal member and the distal linkage member to beangularly offset from each other, such that the distal linkage membercauses a proximal translation of the pusher bar.

A longitudinal axis, defined by a reference axis between the proximalend of the proximal linkage member and the distal end of the distallinkage member, and the proximal linkage member define a first acuteangle on a first side of the longitudinal axis, and the pusher bar is ina proximal position. The distal translation of the drive channel maycause the proximal linkage member and the distal linkage member to pivotsuch that the first acute angle on the first side of the longitudinalaxis increases until the proximal linkage member and the distal linkagemember are linear to each other and the pusher bar has been distallytranslated via the distal linkage member to a distal position.

Further distal translation of the drive channel causes the proximallinkage member and the distal linkage member to pivot from the side ofthe longitudinal axis to a second side of the longitudinal axis suchthat the proximal linkage member and the longitudinal axis define asecond acute angle and the pusher bar has been proximally translated viathe distal linkage member to a proximal position.

The clip follower is configured to engage the wedge plate and movedistally upon distal translation of the wedge plate, and is configuredto engage the clip carrier and stop proximal movement thereof uponproximal translation of the wedge plate.

The clip applier may further include a jaw assembly having a pair ofjaws extending from an end of the channel assembly, opposite thehousing. The jaw assembly may be adapted to accommodate a clip of theplurality of clips therein and is operable to effect formation of theclip in response to movement of the handles.

The pusher bar may be movable towards the jaws as the handles areapproximated in a first direction by an initial amount in order to movea distal-most clip between the jaws. The pusher bar may be configuredand adapted to move towards the housing as the handles are approximatedan additional amount in the first direction to move the pusher behind adistal-most clip in the plurality of clips.

The drive channel may be configured and dimensioned to at leastpartially surround the jaws and the wedge plate. The drive channel mayinclude a strap extending across a distal end thereof for maintainingthe jaws and the wedge plate within the drive channel.

The drive channel may be moved towards the jaw assembly as the at leastone handle is moved actuated in a first direction to move the second endof the drive channel against the jaws to close the jaws, the drivechannel being moved away from the jaws as the at least one handle ismoved a second amount to move the second end of the drive channel awayfrom the jaws to allow the jaws to open.

In embodiments, the clip applier may further include a motion reversingmechanism operatively connected to the wedge plate and the drivechannel. The rotation of the motion reversing mechanism, during distalmovement of the drive channel, results in proximal movement of the wedgeplate.

In embodiments, the clip applier may further include a clip followerslidably disposed within the channel of the clip carrier and disposedproximally of the plurality of clips, the clip follower being configuredand adapted for selective engagement with the windows of the clipcarrier and the apertures of the wedge plate. The clip follower may beconfigured and adapted to urge the plurality of clips, in a distaldirection relative to the clip carrier, upon reciprocal movement of thewedge plate.

In embodiments, the clip applier may further include a motion reversingmechanism operatively connected to the drive channel and the wedge plateand selectively engageable with the pusher bar. The rotation of themotion reversing mechanism, during the distal translation of the drivechannel, results in proximal movement of the wedge plate and the pusherbar.

In embodiments, the clip applier may further include a ratchetmechanism. The ratchet mechanism may further include a rack, having aplurality of ratchet teeth, associated with the drive channel; and apawl, having at least one tooth, disposed at a location to selectivelyengage the rack. The pawl may be biased into engagement with the rack,wherein as the drive channel is longitudinally reciprocated, theplurality of teeth are passed over the pawl. The pawl may preventinadvertent return of the drive channel before full actuation of the atleast one handle.

In embodiments, the clip applier may further include a lockout disposedin a distal end of the channel assembly. The lockout may be actuated bythe clip follower when a last clip is expelled from the clip applier.The lockout may be urged by the clip follower to extend across a path ofthe drive channel, thereby preventing the drive channel from movingdistally.

In embodiments, the clip applier may further include a counter displaymechanism supported in at least one of the housing and the channelassembly. The counter display mechanism is configured and adapted todisplay a change in status of the clip applier upon each actuation ofthe at least one handle.

BRIEF DESCRIPTION OF THE DRAWINGS

The present clip applier will be more fully appreciated as the samebecomes better understood from the following detailed description whenconsidered in connection with the following drawings, in which:

FIG. 1 is a perspective view of a surgical clip applier according to anembodiment of the present disclosure;

FIG. 1A is a rear, perspective view of the surgical clip applier of FIG.1, shown with a shipping wedge in position;

FIG. 1B is a cross-sectional view as taken through 1B-1B of FIG. 1A;

FIG. 1C is a cross-sectional view as taken through 1C-1C of FIG. 1A;

FIG. 2 is a top, plan view of the surgical clip applier of FIG. 1;

FIG. 3 is a side, elevational view of the surgical clip applier of FIGS.1 and 2;

FIG. 4 is an exploded perspective view of the surgical clip applier ofFIGS. 1-3;

FIG. 4A is a perspective view of a motion multiplier system of thesurgical clip applier of FIGS. 1-4;

FIG. 4B is an exploded perspective view of the motion multiplier systemof the surgical clip applier of FIGS. 1-4;

FIG. 4C is a top, perspective view of a pivot arm of the surgical clipapplier of FIGS. 1-4;

FIG. 4D is a bottom, perspective view of the pivot arm of FIG. 4C;

FIG. 4E is a top, perspective view of a clip follower of the surgicalclip applier of FIGS. 1-4;

FIG. 4F is a perspective view of an audible/tactile indicator of thesurgical clip applier of FIGS. 1-4;

FIG. 4G is a perspective view of a rack member of the surgical clipapplier of FIGS. 1-4;

FIG. 4H is a top, perspective view of a surgical clip;

FIG. 4I is a bottom, perspective view of the surgical clip of FIG. 4H;

FIG. 4J is a front, cross-sectional view of the surgical clip of FIG.4H, as taken through 4J-4J of FIG. 4H;

FIG. 5 is a longitudinal cross-sectional view of the surgical clipapplier of FIGS. 1-4, illustrating the surgical clip applier in anunactuated condition;

FIG. 6 is an enlarged view of the indicated area of detail of FIG. 5;

FIG. 7 is an enlarged view of the indicated area of detail of FIG. 5;

FIG. 8 is an enlarged view of the indicated area of detail of FIG. 5;

FIG. 9 is a cross-sectional view of the surgical clip applier of FIGS.1-4, as taken through 9-9 of FIG. 8;

FIG. 10 is a perspective view of the surgical clip applier of FIGS. 1-4,illustrated with an upper housing half removed therefrom;

FIG. 11 is an enlarged view of the surgical clip applier of FIGS. 1-4,as shown in FIG. 10;

FIG. 12 is a top, perspective view of a distal end of a channel assemblyof the surgical clip applier of FIGS. 1-4, with a cover removedtherefrom;

FIG. 13 is a top, perspective view of the surgical clip applier of FIGS.1-4, illustrated with the upper housing half and a pusher bar removedtherefrom;

FIG. 14 is a top, perspective view of a distal end of the channelassembly of FIG. 12, with the cover and the pusher bar removedtherefrom;

FIG. 15 is a top, perspective view of a distal end of the channelassembly of FIG. 12, with the cover, the pusher bar and a clip carrierremoved therefrom;

FIG. 16 is a top, perspective view of a distal end of the channelassembly of FIG. 12, with the cover, the pusher bar, the clip carrier,the surgical clips and the clip follower removed therefrom;

FIG. 17 is an enlarged view of the indicated area of detail of FIG. 16;

FIG. 18 is a top, perspective view of the surgical clip applier of FIGS.1-4, illustrated with the upper housing half, the pusher bar and a wedgeplate removed therefrom;

FIG. 19 is a top, perspective view of a distal end of the channelassembly of FIG. 12, with the cover, the pusher bar, the clip carrier,the surgical clips, the clip follower and the wedge plate removedtherefrom;

FIG. 20 is a top, perspective view of the surgical clip applier of FIGS.1-4, illustrated with the upper housing half, the pusher bar, the wedgeplate and a drive channel removed therefrom;

FIG. 21 is a bottom, perspective view of the surgical clip applier ofFIGS. 1-4, illustrated with a lower housing half, the drive channel andthe wedge plate removed therefrom;

FIG. 22 is a top, plan view of the surgical clip applier of FIGS. 1-4,with the upper housing half removed therefrom and shown in anun-actuated condition;

FIG. 23 is an enlarged view of the indicated area of detail of FIG. 22;

FIG. 24 is an enlarged view of the indicated area of detail of FIG. 22;

FIG. 24A is a schematic illustration of the motion multiplier system ofFIG. 24;

FIG. 25 is a top, plan view of the surgical clip applier of FIGS. 1-4,with the upper housing half removed therefrom and shown during aninitial actuation thereof;

FIG. 26 is an enlarged view of the indicated area of detail of FIG. 25;

FIG. 27 is an enlarged view of the indicated area of detail of FIG. 25;

FIG. 27A is a schematic illustration of the motion multiplier system ofFIG. 27;

FIG. 28 is an enlarged, longitudinal cross-sectional view of the distalend of the channel assembly during the initial actuation of the surgicalclip applier;

FIG. 29 is a top, perspective view of the surgical clip applier of FIGS.1-4, illustrated with the upper housing half and a pusher bar removedtherefrom and shown in during an initial actuation thereof;

FIG. 30 is an enlarged, longitudinal cross-sectional view of the distalend of the channel assembly during a further initial actuation of thesurgical clip applier;

FIG. 31 is bottom, perspective view illustrating the operation of anaudible/tactile indicator during the respective initial actuation of thesurgical clip applier of FIGS. 1-4;

FIG. 32 is a top, plan view of the surgical clip applier of FIGS. 1-4,with the upper housing half removed therefrom and shown during a furtheractuation of the surgical clip applier;

FIG. 33 is an enlarged view of the indicated area of detail of FIG. 32;

FIG. 34 is an enlarged, cross-sectional view illustrating an actuationof a counter mechanism of the surgical clip applier of FIGS. 1-4;

FIG. 35 is an enlarged view of the indicated area of detail of FIG. 32;

FIG. 36 is an enlarged view of a ratchet mechanism shown during thefinal actuation of the surgical clip applier of FIGS. 1-4;

FIGS. 37 and 38 are enlarged perspective view, illustrating the distalend of the channel assembly during the final actuation of the surgicalclip applier of FIGS. 1-4;

FIG. 39 is a top, plan view of the surgical clip applier of FIGS. 1-4,with the upper housing half removed therefrom and shown at a finalcondition after an actuation of the surgical clip applier;

FIG. 40 is an enlarged view of the indicated area of detail of FIG. 39;

FIG. 41 is an enlarged view of the indicated area of detail of FIG. 39;

FIG. 41A is a schematic illustration of the motion multiplier system ofFIG. 41;

FIG. 42 is an enlarged view illustrating the position of theaudible/tactile indicator following an actuation of the surgical clipapplier of FIGS. 1-4;

FIG. 43 is a top, plan view of the jaw assembly illustrating theposition of the jaw assembly following an actuation of the surgical clipapplier of FIGS. 1-4;

FIG. 44 is a perspective view of a body vessel including a clip of thesurgical clip applier, shown applied thereto;

FIG. 45 is an enlarged view of the indicated areas of detail of FIGS.22, 25, 32, and 39, illustrating the operation of the pivot arm duringan opening or release of the surgical clip applier following a completeactuation thereof;

FIG. 46 is an enlarged view of the ratchet mechanism shown during theopening or release of the surgical clip applier of FIGS. 1-4;

FIG. 47 is an enlarged view illustrating the operation of theaudible/tactile indicator during the opening or release of the surgicalclip applier of FIGS. 1-4;

FIGS. 48 and 49 are longitudinal, cross-sectional views of the channelassembly illustrating the movement of the clip follower during theopening or release of the surgical clip applier of FIGS. 1-4;

FIGS. 50 and 51 are longitudinal, cross-sectional views of the distalend of the channel assembly illustrating the movement of the pusher barand wedge plate during the opening or release of the surgical clipapplier of FIGS. 1-4; and

FIG. 52 is a longitudinal, cross-sectional view of the distal end of thechannel assembly illustrating the surgical clip applier of FIGS. 1-4 ina locked-out condition following firing of the last surgical cliptherefrom.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of surgical clip appliers in accordance with the presentdisclosure will now be described in detail with reference to the drawingfigures wherein like reference numerals identify similar or identicalstructural elements. As shown in the drawings and described throughoutthe following description, as is traditional when referring to relativepositioning on a surgical instrument, the term “proximal” refers to theend of the apparatus which is closer to the user and the term “distal”refers to the end of the apparatus which is further away from the user.

FIGS. 1-5 illustrate a surgical clip applier in accordance with anembodiment of the present disclosure and is generally designated as 100.Reference may be made to U.S. Provisional Application No. 61/091,467,filed on Aug. 25, 2008, entitled “Surgical Clip Applier” and U.S.Provisional Application No. 61/091,485, filed on Aug. 25, 2008, entitled“Surgical Clip Applier and Method of Assembly,” the entire contents ofeach of which being incorporated herein by reference, for a detaileddiscussion of the structure, operation, and method of assembly ofsurgical clip applier 100.

Surgical clip applier 100 is a surgical instrument including a handleassembly 102 including a housing 104 having an upper housing half 104 aand lower housing half 104 b. Handle assembly 102 further includes apair of handles 106 pivotably secured to housing 104 and extendingoutwardly therefrom. A channel assembly 108 is fixedly secured tohousing 104 and extends outwardly therefrom, terminating in a jawassembly 110.

As seen in FIGS. 1-4, housing halves 104 a and 104 b of clip applier 100fit together by snap fit engagement with one another. Housing 104defines a window 104 c formed in lower housing half 104 b for supportingand displaying a counter mechanism, as will be discussed in greaterdetail below. Housing 104 is formed of a suitable plastic material.

As seen in FIG. 4, handles 106 are secured to housing 104 by handlepivot posts 104 d extending from lower housing half 104 b and intorespective apertures 106 a formed in handles 106. Handle assembly 102includes a link member 122 pivotally connected to each handle 106 at apivot point 106 b formed in a respective handle 106. A distal end 122 aof each link member 122 is pivotally connected to a pivot point 140 aformed in a drive channel 140 via a drive pin 124. Each end of drive pin124 is slidably received in an elongate channel 104 e formed in arespective upper and lower housing half 104 a, 104 b. In use, as will bedescribed in greater detail below, as handles 106 are squeezed, linkmembers 122 push drive channel 140 distally via drive pin 124.

Channel assembly 108 includes a channel or cartridge cover 130 and anouter or lower channel 132 each having a proximal end retained inhousing assembly 102, between upper and lower housing halves 104 a, 104b. Cartridge cover 130 includes at least one retention element 130 aconfigured and adapted to selectively engage, in a snap-fit engagement,a complementary or corresponding retention element 132 a provided onouter channel 132.

As seen in FIGS. 4 and 6-12, clip applier 100 includes a clip pusher bar160 slidably disposed beneath cartridge cover 130. Pusher bar 160includes a distal end 160 a defining a pusher 160 c configured andadapted to selectively engage/move a distal-most clip “C1” stored insurgical clip applier 100. Pusher bar 160 further includes a proximalend 160 b defining a first proximal window 160 d and a second proximalwindow 160 h therein. First proximal window 160 d is configured forslidably receiving drive pin 124 therein and second proximal window 160h is configured for slidably receiving fixed rod 154 a therein. Pusherbar 160 further defines a distal window 160 e and a proximal window 160g therein for operative engagement with a stabilizer 162, as will bediscussed in greater detail below. Pusher bar 160 further includes anaperture 160 f configured to receive a sliding post 158 c of a distallinkage member 158, as will described in greater detail below.

Clip applier 100 further includes a stabilizer 162 configured to overlieand engage pusher bar 160. Stabilizer 162 includes a distal tab 162 aconfigured to engage distal window 160 e of pusher bar 160, elongatewindows 162 b and 162 d defined therein at a location to substantiallyoverlie and be in registration with respective proximal windows 160 dand 160 h formed in pusher bar 160. As seen in FIGS. 4 and 6, stabilizer162 further includes a plurality of tabs 162 e extending from a topsurface thereof, at a proximal and a distal location, which areconfigured and dimensioned for receipt in respective channels formed inupper housing half 104 a. Stabilizer 162 further includes an aperture162 f that overlies aperture 160 f of pusher bar 160. Apertures 160 fand 162 f are both configured to receive sliding post 158 c of distallinkage member 158.

As seen in FIGS. 4, 4A, 4B, and 24, clip applier 100 further includes amotion multiplier system 155 in the form of a three-bar linkage systemhaving a proximal linkage member 154 that is pivotally supported inhousing 104 and operatively connected to drive channel 140 via apivoting drive arm 156. Pivoting drive arm 156 is pivotably coupled by apin 156 a via aperture 156 b to housing 104. Motion multiplier system155 further includes a distal linkage member 158 that interconnectsproximal linkage member 154 and pusher bar 160. A longitudinal axis “X1”is defined along an axis extending through fixed rod 154 a of proximallinkage member 154 and sliding post 158 c of distal linkage member 158.A side of longitudinal axis “X1,” that includes pivoting drive arm 156,defines a first side and the other side of longitudinal axis “X1”defines a second side. On the first side, proximal linkage member 154 ispivotally oriented at an angle “α” relative to longitudinal axis “X1”(as shown in FIG. 24). On the second side, proximal linkage member 154is pivotally oriented at an angle “−α” relative to longitudinal axis“X1” (as shown in FIG. 35). In essence, when proximal linkage member 154is oriented between angle “α” and angle “−α,” the angle is 0°, such thatproximal linkage member 154 is aligned with longitudinal axis “X1” (asshown in FIG. 27). In this configuration, proximal linkage member 154 isalso aligned with distal linkage member 158, as will be discussed ingreater detail below. Pivoting drive arm 156 is pivotally supported viaa pivot pin 156 a secured and driven by drive channel 140. Alongitudinal axis “X2” is defined along an axis extending along drivechannel 140. In this manner, pivoting drive arm 156 is pivotallyoriented at an angle “β” relative to longitudinal axis “X2” (as shown inFIG. 24).

Proximal linkage member 154 includes a hub 154 b that is configured toreceive a fixed rod 154 a therethrough, such that a pivotable connectionbetween proximal linkage member 154 and housing 104 is established.Proximal linkage member 154 also includes a proximal aperture 154 c anda distal aperture 154 d. Proximal aperture 154 c is configured toreceive a driving post 156 c of pivoting drive arm 156 that selectivelydrives proximal linkage member 154 in a rotational manner, as will bediscussed in greater detail below. Distal aperture 154 d is configuredto receive a coupling pin 158 a via aperture 158 b of distal linkagemember 158 that pivotally couples proximal linkage member 154 to distallinkage member 158. Distal linkage member 158 further includes a post158 c that is slidably connected to aperture 160 f of pusher bar 160 andaperture 162 f of stabilizer 162. Distal linkage member 158 via slidingpost 158 c effectuates translation of pusher bar 160 and stabilizer 162in a proximal and distal direction.

Clip applier 100 further includes a clip carrier 170 disposed withinchannel assembly 108 and beneath pusher bar 160. Clip carrier 170 isgenerally a box-like structure having an upper wall 170 a, a pair ofside walls 170 b and a lower wall 170 c defining a channel 170 dtherethrough. Clip carrier 170 includes a plurality of spaced apartwindows 172 formed in upper wall 170 a and extending longitudinallyalong a length thereof. Clip carrier 170 includes an elongate window 170e (as shown in FIG. 9) formed in lower wall 170 c and extendinglongitudinally along a length thereof.

As seen in FIGS. 4H-4J, a surgical clip “C” includes a first leg “C2”and a second leg “C4.” Each of legs “C2” and “C4” of surgical clip “C”are connected to one another to form an apex “C14.” Apex “C14” ofsurgical clip “C” has a generally V-shaped configuration as shown inFIGS. 4H-4I. First leg “C2” of surgical clip “C” further includes agripping pattern “C6” on an interior wall that defines a plurality ofrecesses “C8.” Second leg “C4” of surgical clip “C” includes a pluralityof indentations “C10” on an exterior wall and a plurality of protrusions“C12” on an interior wall. When surgical clip “C” is applied to tissue,as the application a clip “C” to tissue will be described in greaterdetail below, legs “C2” and “C4” come together, such that plurality ofindentations “C10” and plurality of protrusions “C12” grip and hold atissue therebetween. For a more detailed discussion of surgical clip“C,” please refer to commonly owned U.S. Patent Publication No.2007/0173866, filed on Jan. 23, 2006, entitled “Surgical HemostaticClip,” the entire contents of which is incorporated herein by referencein its entirety.

As seen in FIGS. 4, 9 and 14, a stack of surgical clips “C” is loadedand/or retained within channel 170 d of clip carrier 170 in a manner soas to slide therewithin and/or therealong. Channel 170 d is configuredand dimensioned to slidably retain a stack or plurality of surgicalclips “C” in tip-to-tail fashion therewithin.

As seen in FIGS. 12 and 14, a distal end of clip carrier 170 includes apair of spaced apart, resilient tangs 171. Tangs 171 are configured andadapted to selectively engage a backspan of a distal-most surgical clip“C1” of the stack of surgical clips “C” retained within carrier 170.

As seen in FIGS. 4, 4E, 7 and 15, clip applier 100 further includes aclip follower 174 slidably disposed within channel 170 d of clip carrier170. As will be discussed in greater detail below, clip follower 174 ispositioned behind the stack of surgical clips “C” and is provided tourge the stack of clips “C” forward during an actuation of clip applier100. As will be described in greater detail below, clip follower 174 isactuated by the reciprocating forward and backward motion of wedge plate180.

As seen in FIGS. 4E and 7, clip follower 174 includes body portion 174 adefining a plane, a distal tab 175 extending substantially upwardly andrearwardly from body portion 174 a, and a proximal tab 176 extendingsubstantially downwardly and rearwardly from body portion 174 a. Distaltab 175 includes a distal portion 175 a extending downwardly below theplane defined by body portion 174 a and a proximal portion 175 bextending upwardly above the plane defined by body portion 174 a.

Proximal portion 175 b of distal tab 175 is configured and dimensionedto selectively engage windows 172 formed in upper wall 170 a of clipcarrier 170. In use, engagement of proximal portion 175 b of distal tab175 of clip follower 174 in a window 172 formed in upper wall 170 a ofclip carrier 170 prevents clip follower from traveling or moving in aproximal direction.

Proximal tab 176 is configured and dimensioned to selectively engagewindows 180 b formed in wedge plate 180. In use, engagement of proximaltab 176 of clip follower 174 in a window 180 b formed in wedge plate 180allows for clip follower 174 to be advanced or moved distally upon adistal movement of wedge plate 180.

As seen in FIGS. 4, 7-9, 16 and 17, clip applier 100 further includes awedge plate 180 slidably disposed within handle assembly 102 and channelassembly 108. Wedge plate 180 is positioned or disposed below clipcarrier 170. Wedge plate 180 includes a substantially tapered distal end180 a for selective operative interposition between jaws 120. Wedgeplate 180 defines a plurality of spaced apart windows or apertures 180 bextending longitudinally along a length thereof and formed in a raisedsection thereof, a distal window or aperture 180 c located distal ofapertures 180 b, and a proximal-most transversely oriented slot 180 dlocated proximal of aperture 180 c.

As seen in FIGS. 4, 8, 16 and 17, clip applier 100 includes a distallockout 178 supported by cartridge cover 130. Distal lockout 178includes a tail or tab 178 a extending substantially rearwardly anddownwardly and being configured and dimensioned for receipt in distalwindow or aperture 180 c of wedge plate 180.

As seen in FIGS. 4, 4C, 4D, 6, 11, 13, 18 and 20, clip applier 100includes a wedge plate motion reversing mechanism, in the form of apivot arm 179, pivotally supported in lower housing half 104 b ofhousing 104 for transmitting the translation of drive channel 140 to areverse translation of wedge plate 180. Pivot arm 179 includes a pivotboss 179 a configured for pivotable connection to housing 104, a firststem or finger 179 b provided at one end of pivot arm 179 and extendingin a direction opposite to pivot boss 179 a, and second stem or finger179 c provided at a second end of pivot arm 179 and extending in adirection alongside first stem or finger 179 b and pivot boss 179 a.First stem or finger 179 b is configured and adapted for engagement inproximal-most slot 180 d of wedge plate 180. Second stem or finger 179 cis configured for engagement in a slot 140 g formed in drive channel 140which is connected in a window 140 g defined in a drive channel 140.Slot 140 g includes a longitudinally extending distal portion and alongitudinally extending proximal portion that are axially andtransversely offset from one another, and a transverse portioninterconnecting the distal and proximal portions.

In use, as will be discussed in greater detail below, as drive channel140 is moved distally, after a dwell period (i.e., the length of thelongitudinally extending distal portion of slot 140 g of drive channel140), second stem or finger 179 c is moved in a distal direction,rotating pivot arm 179 and thereby moving first stem or finger 179 b ina second direction. As first stem or finger 179 b is moved in the seconddirection, first stem or finger 179 b pulls wedge plate 180 out frombetween jaws 120 urges against. As wedge plate 180 is moved in a distaldirection, as seen n FIG. 17, distal end 180 a of wedge plate 180 camsagainst an inner surface of jaws 120 to thereby maintain jaws 120 spacedapart from one another.

As seen in FIGS. 4, 6-11, 13, 18 and 19, clip applier 100 includes adrive channel 140 reciprocally supported in and extending betweenhousing 104 of handle assembly 102 and channel assembly 108. A proximalend of drive channel 140 is supported between upper and lower housinghalves 104 a, 104 b of housing 104 and a distal end of drive channel 140is supported between cartridge cover 130 and outer channel 132 ofchannel assembly 108, at a location below wedge plate 180.

A distal end of drive channel 140 is a substantially U-shaped channelincluding a pair of spaced apart side walls 140 b extending from abackspan 140 c thereof, in a direction away from outer channel 132 andtoward cartridge cover 130. Drive channel 140 further defines a drivepin recess 140 a formed in backspan 140 c for pivotally receiving drivepin 124 therethrough. Drive channel 140 further defines a rib 140 eprojecting from backspan 140 c at a location distal of drive pin recess140 a. Drive channel 140 further defines a reciprocation limiting slot140 f formed in backspan 140 c at a location distal of slot 140 e.

As seen in FIGS. 4, 8, 9, 12, 14-16 and 19, clip applier 100 includes adrive channel strap 143 secured to drive channel 140. Strap 143 issecured to uprights 140 b of drive channel 140 so as to extendtransversely thereacross. Strap 143 is secured to drive channel 140 at alocation distal of reciprocation limiting slot 140 f. Strap 143 issecured to drive channel 140 such that wedge plate 180 extends beneathstrap 143 and above jaws 120.

As seen in FIGS. 4, 4F, 6, 10 and 21, clip applier 100 further includesan audible/tactile indicator 148 connected to drive channel 140 viadrive pin 124. Indicator 148 includes a resilient finger 148 a and apair of bosses 148 b. In use, as will be described in greater detailbelow, as clip applier 100 is actuated and drive channel 140 isreciprocated, first resilient finger 148 a of indicator 148 interactswith corresponding complementary structure or ledge 149 provided in clipapplier 100 to create an audible and/or a tactile feedback to the user.Bosses 148 b of indicator 148 ride within channel 104 e formed in upperhousing half 104 a and provide support to indicator 148 to preventindicator 148 from rotating.

As seen in FIGS. 4, 6, 10, 11, 13, 18 and 20, clip applier 100 furtherincludes a biasing member 146, in the form of a tension spring,operatively secured to and between a proximal end of drive channel 140and housing 104, tending to maintain drive channel 140 in a retracted orproximal-most position. Biasing member 146 functions to retract orfacilitate retraction of drive channel 140 following formation of a clip“C” positioned between jaws 120.

As seen in FIGS. 4, 4G, 11, 13, 18 and 20, a proximal end of drivechannel 140 includes a ratchet rack member 141 secured to drive pin 124and movable with drive channel 140. Ratchet member 141 includes a slot141 b to slidably receive fixed rod 154 a. Ratchet member 141 furtherincludes a tab 141 c extending from a proximal end thereof that slidablytranslates within lower housing half 104 b. Ratchet rack member 141 isconfigured and adapted to engage with a ratchet pawl 142 supported inhousing 104. Rack member 141 and ratchet pawl 142 define a ratchetmechanism 144. In use, as drive channel 140 is moved axially, rackmember 141 is also moved. Rack member 141 defines a series of rack teeth141 a having a length which allows pawl 142 to reverse and advance backover rack member 141 when rack member 141 changes between proximal anddistal movement as drive channel 140 reaches a proximal-most ordistal-most position.

Pawl 142 is pivotally connected to lower housing half 104 b by a pawlpin 147 at a location wherein pawl 142 is in substantial operativeengagement with rack member 141. Pawl 142 is engageable with rack member141 to restrict longitudinal movement of rack member 141 and, in turn,drive channel 140. Ratchet mechanism 144 further includes a pawl spring145 configured and positioned to bias pawl 142 into operative engagementwith rack member 141. Pawl spring 145 functions to maintain the teeth ofpawl 142 in engagement with the teeth 141 a of rack member 141, as wellas to maintain pawl 142 in a rotated or canted position.

As seen in FIGS. 1-4, 8, 10, 12, 14-17 and 19, clip applier 100 includesa pair of jaws 120 mounted on or at a distal end of channel assembly 108and actuatable by handles 106 of handle assembly 102. Jaws 120 areformed of a suitable biocompatible material such as, for example,stainless steel or titanium.

Jaws 120 are mounted in a distal end of drive channel 140 via one ormore rivets 120 c or the like extending through reciprocation limitingslot 140 f of drive channel 140 such that jaws 120 are longitudinallystationary relative to outer channel 132 and drive channel 140. As seenin FIGS. 12, 14, 17 and 19, jaws 120 define a channel 120 a therebetweenfor receipt of a surgical clip “C1” therein.

As seen in FIGS. 1-4, 6, 11, 13 and 20, clip applier 100 furtherincludes a counter mechanism 190 supported in housing 104 of handleassembly 102. Counter mechanism 190 includes a display 192, a processor194, and an energy source 198 in the form of a battery or the like.Display 192 is a liquid crystal display that displays one or moreoperating parameters of clip applier 100 to the surgeon. The operatingparameter displayed may be an amount or number of remaining clips, anumber of clips that have been used, a position parameter, a surgicaltime of usage, or any other parameter of the procedure.

Counter mechanism 190 includes a tab 192 a, made from PVC, disposedbetween battery or energy source 198 and a contact 194 a of processor194 or between the contacts 194 a of processor 194 to prevent thebattery or energy source 198 from becoming drained during storage. Asseen in FIGS. 1A and 1B, tab 192 a extends out of housing 104 of clipapplier 100 in order to allow for easy removal of the tab therefrom.Once the tab 192 a is removed, battery or energy source 198 comes intoelectrical contact with the contact 194 a of processor 194 or betweenthe contacts 194 a of the processor 194.

Counter mechanism 190 is actuated by nub 140 e formed in drive channel140. In use, as seen in FIG. 36, as drive channel 140 is driven forward,nub 140 e thereof engages contact 194 a causing contact 194 a tocomplete a circuit and trigger processor 194 to perform a function(e.g., reduce the number appearing on display 192 by a give increment orvalue).

As seen in FIGS. 1A and 1C, clip applier 100 includes a shipping wedge200 supported on housing 104 and interposed between handles 106.Shipping wedge 200 functions to maintain handles 106 spaced apart orun-squeezed during a shipment and/or storage of clip applier 100.Shipping wedge 200 is connected to tab 192 a of counter mechanism 190,such that in order for an end user to use clip applier 100, the end usermust remove shipping wedge 200 thereby also removing tab 192 a toactivate counter mechanism 190.

As seen in FIGS. 1A and 1C, shipping wedge 200 includes a body portion202 in the form of a collar, defining a passage 204 configured anddimensioned for receipt of a portion of housing 104 therein. Shippingwedge 200 includes uprights 206 extending outwardly from opposed sidesof body portion 202 and being configured to receive handles 106 therein.Shipping wedge 200 further includes tabs 208 extending inwardly fromopposed sides of uprights 206. Tabs 208 of shipping wedge 200 areconfigured and dimensioned to engage with handles 106 when shippingwedge 200 is properly secured to clip applier 100.

With reference to FIGS. 22-53, the operation of clip applier 100 isprovided. Prior to any initial squeezing of handles 106 of clip applier100, as seen in FIGS. 22-24, the internal components of the clip applier100 are in a so-called “home” position or “starting” position. Moreparticularly, in the “home” position, the drive pin 124 is located at aproximal-most position, pawl 142 is located distal of rack 140 d ofdrive channel 140, second finger 179 c of pivot arm 179 is located at adistal-most position in the distal portion of window 140 g of drivechannel 140 such that wedge plate 180 is located at a distal-mostposition, and no clips “C” are positioned within jaws 120. Since drivepin 124 is at a proximal-most position, pusher bar 160, stabilizer 162,and drive channel 140 are also at a proximal-most position.

As seen in FIG. 24, when drive channel 140 and pusher bar 160 arelocated at the proximal-most position, driving post 156 c of pivotingdrive arm 156 is located at a proximal-most position and secondresilient finger 148 b of indicator 148 is disposed proximal of edge 149formed in lower housing half 104 b. In embodiments, edge 149 may beformed in upper housing half 104 a with slight modification to indicator148. In the “home” position, angle “α” of proximal linkage member 154may range from about 45° to about 60°, while angle “β” of pivoting drivearm 156 may range from about 20° to about 25°. Also, prior to an initialsqueezing of handles 106 of clip applier 100, with wedge plate 180located at a distal-most position, distal end 180 a thereof isinterposed between jaws 120.

As seen in FIGS. 22, 24 and 24A, also in the “home” position couplingpin 158 a of distal linkage member 158 is located on a first side of thelongitudinal axis “X1.”

The following equations are used to calculate the mechanics of themotion multiplier system 155 in a “home” position. The “home” positiondirectly relates to when pusher bar 160 is in the “home” position (i.e.,proximal-most position), for example, when “α” is about 60°.

XP=(2)(L1)(cos α)−(L1)  (1)

where distance “XP” is the distance traveled by sliding post 158 c andlength “L1” is the length of proximal and distal linkage members 154 and156, as shown in FIG. 24A.

XD=(B)+(C)(cos α)−(L2)(cos β)  (2)

where distance “XD” is the distance traveled by pivot post 156 a ofpivoting drive arm 156 along longitudinal axis “X2,” distance “B” isdistance between pivot pin 156 a of pivoting drive arm 156 and fixed rod154 a of proximal linkage member 154 taken along the longitudinal axisof “X1,” distance “C” is the distance between fixed rod 154 a ofproximal linkage member 154 and driving post 156 c of pivoting drive arm156, and length “L2” is the length of pivoting drive arm 156 taken frompivot post 156 a to driving post 156 c, as shown in FIG. 24A.

Also prior to the initial squeeze, there are no clips “C” present withinjaws 120. A clip “C” is first loaded into jaws 120 during the initialsqueezing of handles 106. As seen in FIGS. 25-33, during an initialsqueeze of handles 106 (i.e., a working stroke), distal ends 122 a oflink members 122 are moved distally relative to housing 104. As distalends 122 a of link members 122 are moved distally, drive pin 124 ismoved distally thereby transmitting distal axial movement to drivechannel 140.

Subsequently, as seen in FIGS. 25-31, as drive channel 140 is moveddistally, motion multiplier system 155 moves from the “home” position toan initial actuated position. More particularly, drive channel 140advances in a distal direction, which, in turn, causes pivoting drivearm 156 to move in a distal direction. That is, pivoting drive arm 156pivots and drives proximal linkage member 154 to rotate in a directionsuch that angle “β” increases, for example, but not limited from about22° to about 45°. In this manner, when angle “β” is increased, proximallinkage member 154 is rotated about fixed rod 154 a of proximal linkagemember 154, which, in turn, causes driving post 158 c of distal linkagemember 158 to be driven distally along slot 162 b of stabilizer 162 andproximal window 160 d of pusher bar 160. As driving post 158 c of distallinkage member 158 is driven distally, driving post 158 c of distallinkage member 158 drives pusher bar 160 in a distal direction.

As seen in FIGS. 25, 32 and 33, during the initial squeeze of handles106, indicator 148 is moved distally along with the distal movement ofdrive channel 140. In use, indicator 148 functions to create an audibleclick and/or a tactile vibration, thereby indicating to the user thathandles 106 of surgical clip applier 100 have gone through at least aportion of a stroke. In particular, as seen in FIGS. 32 and 33, ashandles 106 are actuated, first resilient arm 148 a of audible/tactileindicator 148 rides over and/or along a ledge 149 formed in at least oneof upper and lower housing halves 104 a, 104 b and is flexed thereby. Asarm 148 a of audible/tactile indicator 148 reaches the proximal end ofledge 149, resilient arm 148 a snaps over the proximal end of ledge 149and comes into contact with a surface 149 a of ledge 149, therebycreating a first audible sound and a tactile vibration as resilient arm148 a comes into contact with surface 149 a of ledge 149. The firstindication of audible/tactile indicator 148 indicates to the user that aclip “C” has been appropriately loaded.

As seen in FIGS. 28 and 30, also during the initial squeeze of handles106, as pusher bar 160 is moved in a distal direction, pusher 160 cthereof engages a backspan of a distal-most clip “C1” and begins to moveor urge distal-most clip “C1” distally out of clip carrier 170 and intojaws 120. As distal-most clip “C1” is moved distally, tangs 171 of clipcarrier 170 are deflected or cammed out of engagement with distal-mostclip “C1” and return to their un-deflected or un-cammed state to capturea subsequent clip of the stack of clips “C”. During the initial squeezeof handles 106, pusher bar 160 is advanced an amount sufficient to placedistal-most clip “C1” in channels 120 a of jaws 120.

As seen in FIGS. 27 and 31, also during the initial squeeze of handles106, as drive channel 140 is moved in a distal direction, rack member141 of ratchet mechanism 144 is moved distally causing teeth 141 athereof to move into engagement with and over or across a tooth of pawl142. Once rack member 141 of ratchet mechanism 144 is moved intoengagement with pawl 142, drive channel 140 can not return to a home orproximal-most position until rack member 141 has cleared pawl 142.

During the initial squeeze of handles 106, as seen in FIGS. 25-33, drivechannel 140 is moved distally until finger 179 c of pivot arm 179 isengaged by the transverse portion of slot 140 g of drive channel 140(i.e., the dwell). Once the transverse portion of slot 140 g is inabutment with finger 179 c of pivot arm 179 (i.e., after the dwell hasbeen exhausted), further distal movement of drive channel 140 causesfinger 179 c to move and rotate pivot arm 179. Rotation of pivot arm 179causes movement of finger 179 b thereof which, in turn, causes wedgeplate 180 to be pulled in a proximal direction, thereby withdrawingdistal end 180 a thereof from between jaws 120 and allowing for jaws 120to eventually be closed or approximated thus allowing for jaws 120 toeventually be closed or approximated.

Once the required rotation of pivot arm 179 is achieved, pivot arm 179stops rotating as finger 179 c of pivot arm 179 rides through theproximal portion of slot 140 g of drive channel 140. Finger 179 c ofpivot arm 179 remains in the proximal portion of slot 140 g of drivechannel 140 until the stroke of drive channel 140 is completed.

As seen in FIGS. 25-31, during a further squeeze of handles 106, pusherbar 160 is moved distally with drive channel 140, as described above,until pivoting drive arm 156 has reached a position, such that angle “β”is 45°. In this configuration, proximal and distal linkage members 154and 158 are aligned along longitudinal axis “X1” such that angle “α”therebetween is about 0°.

The following equation is used to calculate the mechanics of the motionmultiplier system 155 when in a “fully extended” position. The “fullyextended” position directly relates to when pusher bar 160 is in a“fully extended” position (i.e., distal-most position), for example,when angle “α” is about 0°.

XE=(B)+(C)−(L2)(cos β₀)  (3)

where distance “XE” is the distance between the “home” position of pivotpin 156 a of pivoting drive arm 156 and the “fully extended” position ofpivot pin 156 a of pivoting drive arm 156 taken along longitudinal axis“X2” of drive channel 140, distance “B” is the distance between pivotpin 156 a of pivoting drive arm 156 and fixed rod 154 a of proximallinkage member 154 taken along longitudinal axis “X1”, distance “C” isthe distance between coupling pin 158 c of distal linkage member 158 anddriving post 156 c of pivoting drive arm 156, length “L2” is the lengthof pivoting drive arm 156 taken from pivot post 156 a to driving post156 c, and angle “β₀” is the “fully extended” position angle of angle“β” when angle “α” is about 0°. In this case, angle “β₀” of pivotingdrive arm 156 is about 45°, as described above and shown in FIG. 27A.

As seen in FIG. 31, as drive channel 140 is further advanced distally,drive channel 140 pulls or flexes resilient finger 148 a of indicator148 over a proximal end of ledge 149. In this manner, a first indication(i.e., audible and/or tactile) is created indicating to a user that asurgical clip “C” has been appropriately loaded.

As seen in FIGS. 25 and 27, also in the “fully extended” position,proximal and distal linkage member 154 and 158 are aligned and/orparallel with longitudinal axis “X1.”

Referring now to FIGS. 32-35, during a further squeezing of handles 106,distal ends 122 a of link members 122 are caused to be moved furtherdistally relative to housing 104. As distal ends 122 a of link members122 are moved further distally, drive pin 124 is caused to be movedfurther distally thereby transmitting distal axial movement to drivechannel 140.

As seen in FIGS. 32, 33, and 35, as handles 106 are continuouslysqueezed, pivoting drive arm 156 continues to move in a distal directionsuch that angle “β”, between pivoting drive arm 156 and longitudinalaxis “X2” of drive channel 140, continuously increases as drive channel140 moves in the distal direction to about 90°. This movement alsocauses proximal linkage member 154 (i.e., positioned on the first side)to pivot or move over-center to the second side, with reference tolongitudinal axis “X1”, such that angle between proximal linkage member154 is pivotally oriented at an angle “−α” relative to longitudinal axis“X1” (as shown in FIG. 35). In this manner, as proximal linkage member154 rotates about longitudinal axis “X1,” angle “−α” decreases fromabout 0° to about 60° causing distal linkage member 158 to move in aproximal direction. In this configuration, sliding post 158 c of distallinkage member 158 slides in a proximal direction, which, in turn,slides pusher bar 160 and stabilizer 162 back to a retracted position ora “safe” position. In the “safe” position, other components of clipapplier 100, such as drive bar 140, are still moving in a distaldirection so that clip “C” may be formed between jaw members 120.However, in the “safe” position, pusher bar 160 is safely retracted to aproximal position such that pusher bar 160 does not interfere with clipapplier 100 when jaw members 120 are approximated towards one another.

The following equation is used to calculate the mechanics of the motionmultiplier system 155 when in a “safe” position. The “safe” position, asdiscussed above, directly relates to when pusher bar 160 is in a saferetracted position (i.e., proximal-most position), while othercomponents of clip applier 100, for example, handles 106 are still in aworking stroke.

(L2)−(C)(sin(−α))=A  (4)

where length “L2” is the length of pivoting drive arm 156 taken frompivot post 156 a to driving post 156 c, distance “C” is the distancebetween coupling pin 158 c of distal linkage member 158 and driving post156 c of pivoting drive arm 156 taken along the longitudinal axis “X1,”and distance “A” is the distance between fixed rod 154 a of proximallinkage member 154 and pivot pin 156 a of pivoting drive arm 156 takenalong a reference axis orthogonal to the longitudinal axis “X1,” asshown in FIG. 42B.

With continued reference to FIG. 32-38, during the further squeezing ofhandles 106, with tab 192 a removed from counter mechanism 190, as drivechannel 140 is advanced distally, nub 140 e thereof engages contact 194a of processor 194 thereby completing a circuit and causing processor194 to perform a function, as described above.

Referring now to FIGS. 39-44, clip applier 100 is illustrated during afinal squeezing of handles 106. In this condition, drive channel 140 isat a distal position, pusher bar 160 is at a distal position, wedgeplate 180 is at a proximal position, biasing member 146 is stretched,and pawl 142 is located proximal of rack 140 d.

Additionally, as seen in FIG. 43, with distal end 180 a of wedge plate180 removed from between jaws 120, as drive channel 140 is moved furtherdistally, a distal edge of drive channel 140 and/or drive channel strap143 engages against camming surfaces 120 b of jaws 120 thus causing jaws120 to approximate toward one another and to form surgical clip “C1”interposed therebetween. Since drive channel strap 143 is fixed to drivechannel 140 and moves therewith, drive channel strap 143 functions tocap drive channel 140 so as to maintain jaws 120 within drive channel140 during the approximation of jaws 120 and to maintain wedge plate 180within drive channel 140 during operation of clip applier 100.

As seen in FIG. 44, surgical clip “C1” may be formed or crimped onto avessel “V” or any other biological tissue.

Drive channel 140 is permitted to move distally relative to pusher bar160 due to the translation of bosses 148 b of indicator 148 through slot160 d of pusher bar 160.

Also, as drive channel 140 is fully advanced distally, as seen in FIG.41, rack member 141 of ratchet mechanism 144 is moved distally to alocation beyond pawl 142 such that the teeth 141 a of rack member 141are moved distally of the tooth of pawl 142 thereby disengaging rackmember 141 and pawl 142 from one another. In this manner, drive channel140 is permitted or free to return to a home or proximal-most position.

As seen in FIG. 42, as drive channel 140 is moved distally, resilientarm 148 a of audible/tactile indicator 148 snaps over the distal end ofledge 149 and comes into contact with a surface 149 a of ledge 149,thereby creating an audible sound and/or a tactile vibration. Suchaudible sound and/or tactile vibration coincide with the loading ofsurgical clip “C”.

Referring now to FIGS. 45-52, during an opening or release of handles106, distal ends 122 a of link members 122 are caused to be movedproximally relative to housing 104. As distal ends 122 a of link members122 are moved proximally, drive pin 124 is caused to be moved proximallythereby transmitting proximal axial movement to drive channel 140 and,in turn, pusher bar 160. The proximal movement of drive channel 140 isfacilitated by the constriction of biasing members 146. Alternatively,the release of handles 106 results in biasing member 146 withdrawingdrive channel 140 in a proximal direction.

As drive channel 140 is moved proximally, the distal edge of drivechannel 140 and/or drive channel strap 143 disengages from againstcamming surfaces 120 b of jaws 120 thus freeing jaws 120 for separationfrom one another for reinsertion of distal end 180 a of wedge plate 180therebetween, and to receive another surgical clip “C” therebetween. Inparticular, as drive channel 140 is moved proximally, the transverseportion of slot 140 g acts on finger 179 c to cause pivot arm 179 torotate and cause finger 179 b of pivot arm 179 to urge wedge plate 180distally. As wedge plate 180 is moved in a distal direction, as seen inFIGS. 51 and 52, distal end 180 a of wedge plate 180 is reinserted orreintroduced into jaws 120, thereby spreading jaws 120 apart.

As seen in FIGS. 48 and 49, as wedge plate 180 is moved distally,proximal tab 176 of clip follower 174 engages in a window 180 b of wedgeplate 180 and is thus urged distally a given distance. As clip follower174 is urged distally, stack of clips “C” is also urged distally. Asseen in FIG. 50, when wedge plate 180 reaches a distal-most position,clip channel 170 abuts, engages, urges or otherwise cams againstproximal portion 175 b of distal tab 175 until web 180 f of wedge plate180 rests substantially beneath distal portion 175 a of distal tab 175.In so doing, proximal portion 175 b of distal tab 175 is moved to extendinto an incrementally more distal window 172 of clip channel 170.

As seen in FIGS. 50 and 51, as clip follower 174 is urged forward,moving the stack of clips “C” forward, a distal-most clip “C1” movesdistal of pusher 160 c by camming beneath pusher 160 c of pusher bar 160until distal-most clip “C1” is caught by tangs 171 of clip applier 170.

Turning momentarily to FIG. 47, as drive channel 140 is moved in aproximal direction, arm 148 a of audible/tactile indicator 148 snapsback over ledge 149 and re-sets itself for the next firing stroke orsqueeze of handles 106.

As drive channel 140 is moved further in a proximal direction, drivechannel 140 effectuates proximal movement of pivoting drive arm 156,which, in turn, reverses the movement of the motion multiplier system.

As seen in FIGS. 45-51, while handles 106 are released and drivingchannel 140 is moved in a proximal direction via biasing member 146 (asshown in FIG. 39), coupling pin 156 a of pivoting drive arm 156 moves ina proximal direction such that angle “β,” between pivoting drive arm 156and longitudinal axis “X2” of drive channel 140, continuously decreasesas drive channel 140 also moves in the proximal direction. In thismanner, driving post 158 c of distal linkage member 158 starts to movein a distal direction, such that, pusher bar 160 and stabilizer 162 viasliding post 158 c distally move back to the “fully extended” position.At substantially the same time, as driving post 158 c of distal linkagemember 158 starts to move in a distal direction, angle “−α” of proximallinkage member 154, positioned on the second side of longitudinal axis“X1,” increases from about −60° to about 0°. As drive channel 140further moves in the proximal direction, proximal linkage member 154pivots from the second side to the first side of longitudinal axis “X1,”such that, in the “fully extended” position, proximal and distal linkagemembers 154 and 158 are again pivotally located in alignment with eachother, such that angle “α” is about 0°. In other words, proximal anddistal linkage member 154 and 158 are between the first side and thesecond side of longitudinal axis “X1.”

In this configuration, as driving channel is 140 further continues tomove in the proximal direction, pusher bar 160 is moved proximally withdrive channel 140, as described above, until pivoting drive arm 156 hasreached a position, such that angle “β,” between pivoting drive arm 156and longitudinal axis “X2” of drive channel 140, is about 45°. In thismanner, proximal linkage member 154 moves to the first side, such thatangle “α” starts to increase from about 0° to about 60°.

Subsequently, as drive channel 140 is moved proximally, the reversingmotion multiplier system 155 moves from the “fully extended” position tothe “home” position. More particularly, drive channel 140 advances in aproximal direction, which, in turn, causes pivoting drive arm 156 tomove in a proximal direction. That is, pivoting drive arm 156 pivots anddrives proximal linkage member 154 in a direction such that angle “β,”between pivoting drive arm 156 and longitudinal axis “X2” of drivechannel 140, decreases to about 22° to about 45°. In this manner,proximal linkage member causes distal linkage member to pivotally slideproximally along slot 162 b of stabilizer 162 and proximal window 160 dof pusher bar 160. In this configuration, distal linkage member 158drives pusher bar 160 in a proximal direction.

When drive channel 140 and pusher bar 160 are located at the distal-mostposition, sliding post 156 c of pivoting drive arm 156 is located at adistal-most position and second resilient finger 148 b of indicator 148is disposed proximal of edge 149. Also, as handles 106 of clip applier100 are released, with wedge plate 180 located at a distal-mostposition, distal end 180 a thereof is interposed between jaws 120.Additionally, as drive channel 140 is moved in a proximal direction, nub140 e thereof disengages contact 194 a of processor 194.

Turning now to FIG. 52, a distal end of clip applier 100 is illustratedfollowing a complete stroke or squeezing of handles 106 and after afinal clip has been expelled therefrom. Following firing of the lastclip, as seen in FIG. 52, proximal tab 176 of clip follower is disposedwithin a distal-most aperture or window of apertures 180 b of wedgeplate 180. In this manner, as wedge plate 180 is moved distallyfollowing a firing of a clip, in the manner described above, clipfollower 174 is also moved distally. Accordingly, as clip follower 174is moved distally, distal tab 175 thereof is moved distal of adistal-most window of windows 172 of clip carrier 170. In this manner,proximal portion 175 b of distal tab 175 engages against an innersurface of a top wall of clip carrier 170 and is cammed or urgeddownwardly.

As proximal portion 175 b of distal tab 175 is cammed or urgeddownwardly, distal portion 175 a of distal tab 175 engages against anupper surface of tab 178 a of lockout 178 and cams or urges tab 178 a oflockout 178 downwardly, across a path of strap 143, supported on drivechannel 140, and into distal window 180 c of wedge plate 180. In thismanner, if drive channel 140 is advanced distally, in the mannerdescribed above, strap 143 will abut against tab 178 a of lockout 178and prevent or block strap 143 and, in turn, drive channel 140 frommoving distally. At this stage, pawl 142 is located in a dwell, distalof rack 140 d, and handles 106 are arranged in a fully opened positionand are thus not capable of being opened any further. In thisconfiguration, clip applier is locked out and can no longer be used.

Depending on the size of the surgical clip, the size of components ofclip applier 100 will have to be scaled accordingly. The majority of thecomponents of the various sized clip appliers will be substantiallyidentical to one another. Components size relating to the width of theclips, such as the jaws 120 and the wedge plate 180, or components sizerelating to the length of the clip, such as the pusher bar 160 and thepivot arm 179, are adjusted accordingly. In this manner, each clipapplier, of varying size, will be assembled in substantially the samemanner and the inner mechanism thereof will operate in substantially thesame manner.

For example, clip applier 100 may be provided in a relatively small,medium and large scale, wherein each of the sizes of clip appliersstores and fires a relatively small, medium or large surgical clip.Based on the relative dimensions of the surgical clips, thecorresponding clip appliers, and their corresponding components, must bescaled appropriately. However, in accordance with the presentdisclosure, each of the various sized clip appliers comprise the samecomponent and may be assembled in the same sequence as one another. Inthis manner, a technician assembling the clip appliers will only have tolearn the sequence and/or steps required for the assembly of one of thesizes of clip appliers and, in turn, be able to assemble the other sizesof clip appliers equally, without having to learn a new sequence or stepof assembly.

Accordingly, the assembly method and/or steps for a relatively small,medium or large clip applier are substantially identical to one another.

Many other remaining components or parts are identical or have minorvariations in feature size or scale. However, if desired, the shapes ofthe following parts may be modified in order to achieve the same result,namely, the length of proximal linkage member 154, the length ofpivoting drive arm 156, and/or the length of distal linkage member 158.

It is contemplated that varying the starting angle of angle “α,” forexample, at about 45° versus at about 60°, is more effective, such thatthe angle difference creates a smoother starting action for the workingstroke of clip applier 100. However, when starting angle “α” is about45°, more area is taken up within housing 104 of clip applier 100 due tolonger proximal and distal linkage members 154 and 158 than when thestarting angle “α” is about 60°. All parameters of the motion multipliersystem 155 can and should be individually designed for any configurationneed in the specific device in which the motion multiplier system isconsidered to be implemented within.

It should be understood that the foregoing description is onlyillustrative of the present disclosure. Various alternatives andmodifications can be devised by those skilled in the art withoutdeparting from the disclosure. Accordingly, the present disclosure isintended to embrace all such alternatives, modifications and variances.The embodiments described with reference to the attached drawing figuresare presented only to demonstrate certain examples of the disclosure.Other elements, steps, methods and techniques that are insubstantiallydifferent from those described above and/or in the appended claims arealso intended to be within the scope of the disclosure.

1-20. (canceled)
 21. A surgical clip applier for applying surgical clipsto body tissue, the surgical clip applier comprising: a housing; atleast one handle pivotably connected to the housing; a drive channelreciprocally disposed at least partially within the housing, the drivechannel having a first end operatively connected to the at least onehandle; a pusher bar reciprocally positioned at least partially withinthe housing, the pusher bar having a proximal end operatively connectedto at least one handle and a distal end defining a pusher, wherein thedistal end of the pusher bar is configured for engagement with adistal-most clip of a plurality of clips loaded in the clip applier; anda motion multiplier system having a plurality of linkage membersconfigured to distally move the pusher bar by an incremental amount uponan initial actuation of the at least one handle, and configured toproximally move the pusher bar subsequent to the initial actuation ofthe at least one handle; wherein the plurality of linkages of the motionmultiplier system include: a proximal linkage member pivotally supportedin the housing and operatively connected to the drive channel; apivoting drive arm interconnecting the drive channel and the proximallinkage member; and a distal linkage member interconnecting the proximallinkage member the pusher bar; wherein a distal translation of the drivechannel causes the proximal linkage member to pivotally rotate via thepivoting drive arm, such that the proximal linkage member causes a firstend of the distal linkage member to pivotally rotate in a firstdirection and a second end to slidably move the pusher bar in a distaldirection.
 22. The clip applier according to claim 21, wherein a furtherdistal translation of the drive channel cause the proximal linkagemember to pivotally rotate via the pivoting drive arm, such that theproximal linkage member causes the first end of the distal linkagemember to pivotally rotate in a second direction and the second end toslidably move the pusher bar in a proximal direction.
 23. The clipapplier according to claim 21, wherein a distal translation of the drivechannel causes a pivotal rotation of the proximal linkage member via thepivoting drive arm, wherein the pivotal rotation of the proximal linkagemember causes a pivotal rotation of the distal linkage member, andwherein the pivotal rotation of the distal linkage member causes adistal translation of the pusher bar.
 24. The clip applier according toclaim 23, wherein a further distal translation of the drive channelcauses a further pivotal rotation of the proximal linkage member via thepivoting drive arm, wherein the further pivotal rotation of the proximallinkage member causes a further pivotal rotation of the distal linkagemember, and wherein the further pivotal rotation of the distal linkagemember causes a proximal translation of the pusher bar.
 25. The clipapplier according to claim 23, wherein when the proximal linkage member,the distal linkage member, the pivoting drive arm, the drive channel andthe pusher bar are in a first position, the proximal linkage member andthe distal linkage member define a first angle, wherein proximaltranslation of the drive channel causes the proximal linkage member andthe distal linkage member, via the pivoting drive arm, to pivotallyrotate thereby increasing the first angle to a second angle of about 180degrees such that the proximal linkage member and the distal linkagemember are linear to each other, such that the proximal linkage member,the distal linkage member, the pivoting drive arm, the drive channel andthe pusher bar are in a second position.
 26. The clip applier accordingto claim 25, wherein when the proximal linkage member, the distallinkage member, the pivoting drive arm, the drive channel and the pusherbar are in the second position, further proximal translation of thedrive channel causes the proximal linkage member and the distal linkagemember, via the pivoting drive arm, to pivotally rotate therebydecreasing the second angle of about 180 degrees to a third angle, suchthat the distal linkage member, the pivoting drive arm, and the drivechannel are in a third position, while the pusher bar is in the firstposition.
 27. The clip applier according to claim 23, wherein therotation of the proximal linkage member via the pivoting drive armcauses the proximal linkage member and the distal linkage member to belinear to each other and along a longitudinal axis defined by areference axis between the proximal end of the proximal linkage memberand the distal end of the distal linkage member, such that the distallinkage member causes a distal translation of the pusher bar.
 28. Theclip applier according to claim 27, wherein further rotation of theproximal linkage member via the pivoting drive arm causes the proximalmember and the distal linkage member to be angularly offset from eachother, such that the distal linkage member causes a proximal translationof the pusher bar.
 29. The clip applier according to claim 23, wherein alongitudinal axis, defined by a reference axis between the proximal endof the proximal linkage member and the distal end of the distal linkagemember, and the proximal linkage member define a first acute angle on afirst side of the longitudinal axis, and the pusher bar is in a proximalposition, wherein distal translation of the drive channel causes theproximal linkage member and the distal linkage member to pivot such thatthe first acute angle on the first side of the longitudinal axisincreases until the proximal linkage member and the distal linkagemember are linear to each other and the pusher bar has been distallytranslated via the distal linkage member to a distal position.
 30. Theclip applier according to claim 29, wherein further distal translationof the drive channel causes the proximal linkage member and the distallinkage member to pivot from the side of the longitudinal axis to asecond side of the longitudinal axis such that the proximal linkagemember and the longitudinal axis define a second acute angle and thepusher bar has been proximally translated via the distal linkage memberto a proximal position.
 31. The clip applier according to claim 21,further comprising: a clip carrier at least partially disposed withinthe housing and defining a channel and a plurality of windows therein; aplurality of clips slidably disposed within the channel of the clipcarrier; a wedge plate reciprocally disposed at least partially withinthe housing and being operatively connected to the at least one handle,the wedge plate defining a plurality of apertures formed along a lengththereof; and a clip follower disposed within the channel of the clipcarrier and engageable with the plurality of windows of the clip carrierand the plurality of apertures of the wedge plate; wherein the clipfollower is configured to engage the wedge plate and move distally upondistal translation of the wedge plate, and is configured to engage theclip carrier and stop proximal movement thereof upon proximaltranslation of the wedge plate.
 32. The clip applier according to claim31, further comprising a jaw assembly including a pair of jaws extendingfrom a distal end of the channel assembly, the jaw assembly adapted toaccommodate a clip of the plurality of clips therein and being operableto effect formation of a clip disposed therewithin in response tomovement of the at least one handle.
 33. The clip applier according toclaim 32, wherein the pusher bar is movable towards the pair of jaws asthe at last one handle is actuated in a first direction by an initialamount in order to move a distal-most clip of the plurality of clipsbetween the pair of jaws, and the pusher bar being configured andadapted to move towards the housing as the at least one handle isactuated an additional amount in the first direction to move the pusherbehind a new distal-most clip of the plurality of clips.
 34. The clipapplier according to claim 33, wherein the drive channel is configuredand dimensioned to at least partially surround the pair of jaws and thewedge plate, wherein the drive channel includes a strap extending acrossa distal end thereof for maintaining the pair of jaws and the wedgeplate within the drive channel.
 35. The clip applier according to claim33 wherein the drive channel is moved towards the pair of jaws as the atleast one handle is actuated in a first direction to move the second endof the drive channel against the pair of jaws to close the pair of jaws,the drive channel being moved away from the pair of jaws as the at leastone handle is moved a second amount to move the second end of the drivechannel away from the pair of jaws to allow the pair of jaws to open.36. The clip applier according to claim 35, further comprising a motionreversing mechanism operatively connected to the wedge plate and thedrive channel, wherein rotation of the motion reversing mechanism,during distal movement of the drive channel, results in proximalmovement of the wedge plate.
 37. The clip applier according to claim 31,wherein the clip follower is configured and adapted for selectiveengagement with the windows of the clip carrier and the apertures of thewedge plate, wherein the clip follower is configured and adapted to urgethe plurality of clips, in a distal direction relative to the clipcarrier, upon reciprocal movement of the wedge plate.
 38. The clipapplier according to claim 31, further comprising: a motion reversingmechanism operatively connected to the drive channel and the wedge plateand selectively engageable with the pusher bar, wherein rotation of themotion reversing mechanism, during the distal translation of the drivechannel, results in proximal movement of the wedge plate and the pusherbar.